Search results for " preparative"

Article Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …

Article Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2 A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…

Article Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…

Article Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…

Article Driving Change in Biomanufacturing
Whatever the objective, driving change is a challenge. Implementing a new technology into a bioprocess is a big change. The new technology must be fully understood, all regulatory requirements fulfi…

Article Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development. The structures of protein drugs such as monoclonal antibodies are mad…

Article Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process. By Marcos Simon, Juan J. Giner-Casares Cell…

Article Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis. By Michiel E. Ultee, PhD, Dr. Richard Easton This article reviews the implications of cell-culture co…

Article Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics. By Robert Karlsson Abstract Biotherapeutic antibodies are still the larg…

Article The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture. By Andrew Harrison, Susan J. Schniepp The long awaited, anxio…

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